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Jurnal Internasional 5 PDF
Jurnal Internasional 5 PDF
1 (2013): 56-64
Abstract.Nowadays, the pharmaceutical industry has a market tends to be unstable and volatile in meeting
customer needs. This is due to the economic crisis that occurred in different parts of the world. The
pharmaceutical industry currently uses good manufacturing practices (cGMP) to ensure that products are
consistently produced and controlled according to the required standards. Pharmaceutical industry slowly
started to move from cGMP to lean manufacturing that focused on reducing operating costs while ensuring
compliance. The problem faced at the OBH (Black Cough Medicine) production line in this company is
inconsistent production of the product to the market. Therefore, the purpose of this paper is to analyze the usage
of lean manufacturing instead of the usage of cGMP to solve the problem. To conduct this study, literature
review and company visit has been done. This analysis was applied by using value stream mapping (VSM) and
7 -wastes methodology to analyze the problems in the OBH production line one of the pharmaceutical industry in
Bandung, Indonesia. For the improvement, the lean manufacturing approach has been carried out and the future
VSM has been developed. Finding reveals that the application of lean manufacturing in the cGMP environment
helps the company to eliminate wastes in reducing lead time and cycle time in the manufacturing process.
Keywords: Pharmaceutical Industry, cGMP, Lean Manufacturing, Value Stream Mapping, 7-Wastes.
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Pramadona and Adhiutama, The Application of Lean Manufacturing for Operation Improvement: A Case Study of Black
Cough Medicine Production in Indonesia
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The Asian Journal of Technology Management Vol6. No.1 (2013):56-64
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Pramadona and Adhiutama, The Application of Lean Manufacturing for Operation Improvement: A Case Study of Black
Cough Medicine Production in Indonesia
Continue (Table 2. Comparison between Lean and cGMP ) developed is shown in Figure 1.The information
obtain fro m current VSM indicates that the
Area LEAN cGMP process involve a total of six processes, they are
Typical Reduce cost Follow validated bottle washing, mixing, filtration, filling &
goals process capping, visual test, and labeling & packaging.
Improve quality P revent deviation The bottleneck occurs at the mixing process in
Reduce cycle which the cycle time is 90 minutes. The
time calculations for the rest of the operations have
Reduce been carried out. The total cycle time (TCT) for
inventory the process is 295 minutes whereas the total
Improve delivery
non-added value (NAV) is 263 minutes.The
Typical Value stream Documentation wastes that occurred in the OBH production
tools mapping
line are shown in Table 3. And the detail of the
Kaizen Personal
improvement qualifications and
current processing time is shown in Table 4.
training
Error proofing Cleanliness
Moving to pull Validation and
qualification
Simple flow Complaint review
Training Audits
Quality function
deployment
(Greene and O’Rourke2006)
3. Result
3.1. Current VSM
Waiting Waiting for Waiting fo r Waiting for Waiting for Waiting for Waitin g for
information informatio n informatio n informatio n informatio n information
Method
(room and (room and (room and (room and (ro om and (room and
machine) machine) machine) machine) machine) machine)
The d istance - - The d istance - -
to mixing to labeling &
Transportatio n Method room is too packaging
far room is too
far
- - - Risk y for - -
Defects Material broken neck
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The Asian Journal of Technology Management Vol6. No.1 (2013):56-64
Labeling
Filling &
7-Wastes Washing Mixing Filtratio n Visual Test &
Capping
Packaging
- Assure the tool - - - Assure the
is clean labels
Man
attached to
the bottles
- Less o f too ls - - - -
Excess Motion Machine
Time (min)
No Process
Current Future
1 Condition room recording 2* 0
2 Washing machine checking 10 10
3 Oven machine checking 15* 0
4 Lead time 15* 0
5 Bottle washing 60 60
6 Condition room recording 3* 0
7 Mixing machine checking 10 10
8 Lead time 5* 0
9 1st initial m ixing 10*
10 2nd initial mixing 10*
11 3rd initial m ixing 10* 10
12 4th initial m ixing 5*
13 5th initial m ixing 5*
14 Lead time 5* 0
15 1st final mixing 20 20
16 Lead time 5* 0
17 2nd final mixing 20 20
18 Sam ple taking 3 3
19 Sam ple test 35 35
20 Lead time 5 5
21 Filtration 20 20
22 Lead time 10 10
23 Condition room recording 3* 0
24 Lead time 7* 0
25 Filling machine checking 15* 0
26 Filling 55 55
27 Lead time 20 10
28 Condition room recording 3* 0
29 Visual test tool checking 7* 0
30 Visual test 15 15
31 Lead time 90* 60
32 Condition room recording 5* 0
33 Labeling and packaging 55 55
Total Cycle Time 295 195
Total Lead Time 263 133
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Pramadona and Adhiutama, The Application of Lean Manufacturing for Operation Improvement: A Case Study of Black
Cough Medicine Production in Indonesia
3.1.1.The Information Flow The raw materials were mixed through two
stages of the process, the initial mixing and
T he PPIC department will manage all the final mixing. Initial mixing process consists of
orders from the customers and translate them 5 stages, a length process respectively 10, 10,
into a monthly master production schedule 10, 5, 5 minutes. While the final mixing process
(MPS) by checking the existing products in the consists of two stages, a length process
finish goods warehouse. The PPIC departments respectively 20 and 20 minutes.
will also make a monthly material recruitment
planning (MRP) by checking the existing raw After the process of mixing finished, raw
materials in the raw materials warehouse. The materials that has been mixed evenly filtered in
MRP will be given to the purchasing division the process of filtration and having an average
for the raw material purchasing and the MPS time process of 20 minutes. A solution has been
will be given to the production department for filtered then included into machine filling and
doing the production. The production capping. The process of filling and capping
department will execute the MPS and give the spent 55 minutes to 2,000 bottles of OBH.
instructions to production personnel on a daily
basis. The information flow is shown in Figure Prior to labeling and packaging process for 55
2. minutes, a visual check process will be done.
Visual checking is done to ensure that there are
3.1.2.The Physical F low no raw materials have been mixed to
perfection. This visual checking length is 15
Bottles that will be used in the process of filling minutes.
and capping washed beforehand to a washing
process for 60 minutes. Any prior conducting 3.2. The 7-Wastes Analysis
processes, beforehand checked the condition of
the room and machine that will be used. A 7-wastes analyzed through the stages of the
washing machine has a capacity of 3,500 production process. The wastes will be seen in
bottles. After the washing process bottles, every stages of the production process ranging
bottles that have been washed stored for use from washing to labeling & packaging based on
during the process of filling and capping. man, machine, material, and method. The 7-
wastes discussions result is shown in Table 2.
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The new sequence of the operation has been This can lead the production time in OBH
developed, the bottle washing process parallel production line to be consistent. Therefore, the
with the mixing process and perform 1 st, 2nd, problems faced by the company, inconsistent
3rd, 4th, 5th initial mixing parallel. By production of the products to the market, can be
performing the parallel process, the processing solved. Knowing for sure the production time,
time of bottle washing as if dispensed and the the company can provide assurance to
processing time of initial mixing can be customers about the arrival time of products to
reduced. the market.
And the last modification is the utilization of The first step that needs to be done in
the new operation tools. The usage of manual implementing lean manufacturing is making
room condition recorder can increase the total current VSM. Current VSM is a tool to
NAV. By utilizing the automatic room recorder determine the value stream flow (Upadhye et al.
can eliminate the waiting time and make cycle 2010). By knowing the value stream flow, we
time faster (Waurzyniak 2007). can identify and categorize the wastes that
occur in operation process through the 7-wastes
Calculations have been carried out for the rest analysis. T he concept of lean manufacturing has
of the new operations, and the total cycle time been used to eliminate non-added value named
(TCT ) for the process is 195 minutes decrease wastes and enhance the operation performance
from 295 minutes whereas the total non-added (Manuele 2007; Rahman et al. 2010).
value (NAV) is 133 minutes decrease from 263
minutes. The detail of the future processing Reduction in cycle time is usually considered
time is shown in Table 3. the best ones attacked by lean principles (Snee
2010).The last step is making the future VSM
by doing various modifications. The various
modifications made must be adjusted to
readiness of a company's management to accept
the proposal given to the application of lean
manufacturingVinodh et al. 2010). One of the
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Pramadona and Adhiutama, The Application of Lean Manufacturing for Operation Improvement: A Case Study of Black
Cough Medicine Production in Indonesia
tools used during this approach is 5S. Although Manos, T. (2006). Value Stream Mapping – an
the company uses the cGMP guidelines, there Introduction. Quality Progress 39 (6): 64-69.
are great opportunities to better organize the
work and this applies throughout the operation, Manuele, F. A. (2007 ). Lean Concepts:
ranging from warehouses, manufacturing, and Opportunities for Safety Professionals.
to the Labs (Maslaton 2012). Professional Safety 52 (8): 28-34.
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Waurzyniak, P., (2007). Automation in Lean Womack, J. P., (2006). Vallue Stream
Manufacturing. Manufacturing Engineering139 Mapping. Manufacturing Engineering 136 (5 ):
(1): 99-105. 145-156.
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